Intravaginal Rings for Contraception

Overseen By Irene Bruce

Age: 18 - 65

Sex: Female

Trial Phase: Phase < 1

Sponsor: Population Council

Disqualifiers: Pregnancy, HIV, STIs, breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 13 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the comfort and usability of new non-medicated intravaginal rings (IVRs) for contraception. Researchers seek to understand how women accept these rings, which are made from different materials. Participants should be sexually active women who have regular vaginal intercourse and use a non-vaginal birth control method, such as pills or an IUD. The trial aims to understand how these rings might fit into everyday life without any medication involved.

As an Early Phase 1 trial, this research focuses on understanding how these innovative rings function in people, offering participants the opportunity to be among the first to experience this new contraceptive option.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must not be using vaginal contraception and should be using an effective non-vaginal method of contraception.

What prior data suggests that these intravaginal rings are safe for contraception?

Research shows that non-medicated intravaginal rings (IVRs), like the Pro-type IVR under study, have been tested for safety in other contexts. Studies on similar IVRs have generally found them to be well-tolerated by users. Materials used for these rings, such as silicone and EVA, are commonly used in medical products and have been shown to be safe.

Specific safety data for the Pro-type IVR is not yet available, as this trial is in its early phase. This phase focuses on assessing the treatment's safety for people, and any serious side effects would likely have been detected by now. The trial's current phase suggests that the treatment is considered safe enough for human testing, although more data will be needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intravaginal rings (IVRs) because they offer a non-medicated, hormone-free option for contraception, distinguishing them from traditional methods like hormonal pills or IUDs. These rings are made from materials like silicone and EVA, focusing on user comfort and acceptability, which are often concerns with current contraceptive methods. By using the Intravaginal Ring Acceptability Scale (IVR-AS), researchers hope to understand user preferences better and potentially increase the adoption of this innovative approach to contraception.

What evidence suggests that this intravaginal ring is effective for contraception?

Research shows that vaginal rings offer a promising option for birth control. Studies have found these rings consistently effective over multiple cycles, with a Pearl Index of 2.98 per 100 woman-years, indicating high effectiveness when used correctly. Many users find vaginal rings comfortable and report high satisfaction in studies. Their ease of use can encourage continued use and improve results. In this trial, participants will compare the acceptability of three different non-medicated intravaginal rings (IVRs) to assess user satisfaction and comfort. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for sexually active cisgender women aged 18-49 in Atlanta, GA who use non-vaginal contraception. They must be healthy, not pregnant or breastfeeding, and free from certain infections and genital issues. Participants agree to avoid other clinical trials during this study.

Inclusion Criteria

I am able to understand and sign the consent form.

I am healthy according to my recent medical exams.

I am a cisgender woman aged 18-49.

Exclusion Criteria

Positive chlamydia, gonorrhea, or trichomoniasis test at screening

I have symptoms of a yeast infection, BV, or UTI currently.

I have had unexplained vaginal bleeding in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants assess the performance attributes and acceptability of three different non-medicated intravaginal rings over a crossover period

13 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pro-type IVR

Trial Overview The study is testing the performance and acceptability of a new type of non-medicated intravaginal ring (Pro-type IVR) among participants. It's an open label crossover trial where each participant will experience using the IVR.

How Is the Trial Designed?

Group I: Proto-type IVR Experimental Treatment 1 Intervention

60 women comparing acceptability of three different non-medicated IVRs (2 silicone and 1 EVA) based on the Intravaginal Ring Acceptability Scale (IVR-AS).

Who Is Running the Clinical Trial?

Population Council

Lead Sponsor

Trials

52

Recruited

63,400+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10350750/

Advances in contraception: vaginal contraceptive rings - PMC Furthermore, there was no change in efficacy across 13 cycles. The Pearl Index for good use was 2.98 (95% CI 2.13–4.06) per 100 woman-years. If ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0168365924007326

Next-generation 3D printed multipurpose prevention ... Here we report the first 3D printed multipurpose prevention technology (MPT) intravaginal ring (IVR) for prevention of HIV, HSV-2, and unintended pregnancy.

3. frontiersin.org frontiersin.org/journals/global-womens-health/articles/10.3389/fgwh.2021.799963/pdf

Acceptability and Satisfaction of Contraceptive Vaginal ... Among NuvaRing® studies, general satisfaction (being satisfied or very satisfied) was between 80 and 90% and tended to mirror continuation.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9128798/

Vaginal ring acceptability: A systematic review and meta ... Secondary outcomes were similarly favorable, including ring comfort (92.9%; 95%CI 89.2, 95.4), ease of use (90.9%; 95%CI 86.5, 94.0), and comfort during sex ( ...

5. contraceptionjournal.org contraceptionjournal.org/article/S0010-7824(21)00410-8/pdf

Vaginal ring acceptability We included studies reporting primary quantitative data on relevant acceptabil- ity outcomes; with women of any age; assessing active, placebo,.

6. dovepress.com dovepress.com/article/download/5637

Examining the efficacy, safety, and patient acceptability of ... 2 Absolute contraindication to the NuvaRing relate mostly to the presence of estrogen (Table 1) and include history of cardiovascular events or venous ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0142961223002685

Next generation 3D-printed intravaginal ring for prevention ... Here we report the first 3D-printed multipurpose prevention technology (MPT) intravaginal ring (IVR) for HIV prevention and contraception.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8277443/

Development of Hormonal Intravaginal Rings - PubMed Central Efficacy and safety of the contraceptive vaginal ring (NuvaRing) compared with a combined oral contraceptive in Chinese women: a 1-year randomised trial ...

9. researchgate.net researchgate.net/publication/221798541_State_of_the_Art_in_Intravaginal_Ring_Technology_for_Topical_Prophylaxis_of_HIV_Infection

(PDF) State of the Art in Intravaginal Ring Technology for ... Medical-grade non-biodegradable polyurethanes have been widely investigated for manufacturing different types of IVRs for contraception [47,53] ...